Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle

Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery

The aim of the present study was to compare the outcomes of incisions made by Colorado® microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: Colorado® microdissection needle; Device: Cautery tip; Device: BP blade

Detailed Description

Commercially, many microdissection needle systems are available, such as Stryker Colorado® microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™ microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide array of applications in the field of Ophthalmology, Neurosurgery, and others.

The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain. The instrument tip is a delicately machined, insulated tungsten diathermy needle that is compatible with any standard cautery hand piece. Tungsten, with its extremely high melting point (>3400°C) provides a heat resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 509002
      • SVS Institute of Dental Sciences, Mahabubnagar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Systemically healthy individuals within the age group of 25-45 years having at least 20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable for modified Widman flap were included in the study.

Exclusion Criteria:

• Patients who underwent periodontal therapy in the past 6 months, medically compromised patients, patients with poorly shielded cardiac pacemakers were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colorado microdissection needle group; In patients selected for Colorado® needle group incision was given with Colorado® needle tip ( N103 A which is 3 cm length straight, 3/32 in sleeve diameter),	Device: Colorado® microdissection needle; The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain.
Experimental: Cautery group; Electrosurgery tip was used to give incisions.	Device: Cautery tip; Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
Active Comparator: BP Blade group; No.15 surgical blade was used to give incisions.	Device: BP blade; Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantity of blood loss in ml	Quantity of blood loss by swab weighing method.	Immediate postoperative volume
PPD in mm	Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.	Baseline to 180 days
Changes in dimensions of interdental papilla in mm	Changes in dimensions of interdental papilla using a periodontal probe.	Baseline to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of postoperative pain:	Postoperative pain was assessed by using visual analogue scale (VAS) which was recorded 1 day, 7 & 15 days after surgery. The visual analogue scale (VAS) consists of a line, usually 10 cm long, whose ends are labelled as the extremes ('no pain' and 'severe pain'). The patients were asked to mark on the line which indicated their pain intensity.	1 day, 7 & 15 days
Assessment of wound healing:	Wound healing was recorded using Early wound healing index (EHI).	1 day, 7 & 15 days

Collaborators and Investigators

• Sponsor: SVS Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Estimate): December 28, 2016
• Last Update Submitted That Met QC Criteria: December 21, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Incisions; microdissection needle
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: SVSIEC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Publication data will be shared